Thomas, Iii, L. G. 　著

内容

目次

Nature of the new drug law: the original drug lag - the United States;the new drug lag - Japan; domestic politics in Japan and the dual state; the50-years war - JMA versus MHW. Industrial policy and domestic ecosystems:domestic ecosystems - firms and industries; the social construction ofindustries; antitrust, trade policy, and the rule of reason. Nature of thedomestic Japanese ecosystem: doctors and pharmaceutical demand; the clinicaltrial system; price regulation and "reform"; scandal and reform of clinicaltrials; the distribution system and reform. Pathologies of the Japaneseecosystem: ultra-short product life; proliferation of minor products;uncompetitive domestic firms; massive over-consumption; exclusion of foreigninnovation; core hypotheses for this study. Evidence - declining prices andlife cycle sales: matched molecules, US, Britain and Japan, 1975; matchedmolecules, US, Britain and Japan, 1986-1996; exclusion, capabilities and therule of reason. Evidence - declining registrations in Japan: breakdown of theregistration process in Japan; clinical trials in Japan; decomposition ofexclusion - registration versus pricing. Evidence -declining launches inJapan: launches of new molecules worldwide; decomposition of exclusion -capabilities again. Evidence: inflated domestic market share in Japan:openness and closure of 12 nations; Japanese exclusion and the rule ofreason. Challenges to the dual state in Japan: industrial policies - supplyand demand articulation; the hypercompetitive shift; demand articulation inUS pharmaceuticals; hypercompetition and Japanese industrial policy. Tradelaw and remedies for market exclusion: why intervene against Japaneseexclusion?; approaches to US intervention against Japanese exclusion; beyond"Gaiatsu" - specifics of US trade action; towards a new global politics ofinnovation.